Track 10: Regulatory CMC and Product Quality
The Regulatory CMC and Product Quality Track has 10 sessions and provides a comprehensive view of risk-based approaches across the product lifecycle. With themes in CMC, Product Quality, New Technology and Innovation, FDA Initiatives, and International Harmonization, the track scope spans from the scientific understanding gained through product and process development to lifecycle expectations for Global Regulatory CMC submissions, CGMP, and Quality Systems. Sessions will address the increasing regulatory complexity of development and manufacturing for worldwide markets, accelerated development timelines, new technologies, emerging regulations, and increased scrutiny of manufacturing operations and data.
Sessions in Regulatory CMC and Product Quality
Monday, June 25
- Office of Pharmaceutical Quality: Removing Barriers to Innovation
- New Technologies in Pharmaceuticals and Biopharmaceuticals: Opportunities and Regulatory Challenges
Tuesday, June 26
- CMC Challenges for Breakthrough Therapies and Other Worldwide Accelerated Approval Programs
- Biosimilars: Demonstrating Structural and Functional Similarity
- ICH M9 BCS-Based Biowaivers
- ICH Q12: A Paradigm Changing Guidance for Post-Approval Changes?
Wednesday, June 27
- Can I Implement That Now? Efficiently Managing Post-Approval CMC Changes
- Modernization and Harmonization of Inspectional Approaches
- Current and Future Perspective on Mutual Recognition, Work Sharing, and Global Regulatory Convergence
Who is This Track Designed For?
Professionals involved in: regulatory affairs, manufacturing, quality assurance, quality control, drug development and/or manufacturing for small molecule drugs, biologics, and vaccines.